News & Announcements
Office of Research Staff MeetingOn December 4th and 5th, Research Integrity staff will be attending an internal office event, and there may be delays in responding to questions during that period.
Research Integrity Winter Break
With the holidays approaching, please pay close attention to submission timelines and please plan any submissions (e.g., new protocols) accordingly.
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Federal Guidelines on Research Security
Earlier this summer the U.S. government released Research Security Guidelines (Guidelines) for universities. This guidance has been under development since 2021 and is intended to help universities develop programs that increase research security awareness while preserving openness in research.
If you receive or are pursuing federal funding support, please take a moment to review the coming requirements. Funding agencies are in the process of developing new policies that address the requirements in the Guidelines, with some agencies already incorporating new requirements into their funding opportunities.
Here is a brief overview of the coming requirements:
Cybersecurity – Institutions will need to certify that they have a cybersecurity program that meets forthcoming standards. The Secure UCSB program will help support meeting this requirement and federally funded researchers will need to follow campus IT requirements and assist in the process of identifying research data which requires even higher levels of protection (e.g., Controlled Unclassified Information, Personal Health Information, Proprietary Information, etc.).
Foreign Travel Security – The government is developing training which will be required at least once every six years. In addition, universities will be required to maintain records of international travel. Several federal agencies will likely impose additional requirements, which may include reporting of proposed international travel directly to the funding agency. As a reminder, UC policy requires registration of international business travel.
Research Security Training – Institutions will be required to provide training on research security. The National Science Foundation has already funded the development of this training, which is available at the NSF’s research security web site. Their training is lengthy and the University of California is in the process of developing more focused training, which will meet this requirement. Once developed, this training will be available through the campus Learning Center. It is likely that federal sponsors will make this an annual requirement.
Export Control Training – Individuals conducting research on export-controlled technologies will be required to complete export control training. Export control training is already available in the campus Learning Center, in addition to one-on-one support from the campus Export Control office.
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Talent Program Certifications
The CHIPS and Science Act of 2022 established a requirement for any individual who contributes in a substantive, meaningful way to the scientific development or execution of a project to certify at proposal submission that they are not a party to a Malign Foreign Talent Recruitment Program (“MFTRP”) and to certify annually thereafter. In response to this federal requirement, on September 16th the Office of Research launched a process to collect certifications through the ORCOI system. For any federal or federally-funded proposal, all PIs, Co-PIs and Key Personnel identified in ORBiT will be prompted to complete a short questionnaire in ORCOI regarding participation in a MFTRP and must certify their response. ORBiT will send an automated email directly to each person listed.
In case you missed previous outreach on this certification process, here is a link to a short video (~15 minutes). For most individuals, completing the annual certification should take no more than a minute or two.
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Outside Activities (OATS) and Research
On July 1st, policy changes took effect for APM-025: Conflict of Commitment and Outside Activities of Faculty Members and Designated Other Academic Appointees. Certain Category I outside activities involving research or appointments at another institution will trigger additional questions. These questions are intended to identify situations in which federal sponsor reporting requirements may apply.
In recent years federal sponsors have emphasized the importance of transparent and complete disclosure of current and pending (other) research support. In some cases, the government has found that researchers have reported foreign research support to their institution, through conflict of commitment or conflict of interest disclosures, but did not report this research support to their federal funding agency. As a reminder, PIs and Key Personnel are required to follow federal funding agency reporting requirements if participating in a federally-funded research project. The major funding agencies have developed a number of tools to assist institutions and researchers. Please find our summary of these requirements on our Other Support website.
As of this academic year, responding in the affirmative to certain questions in OATS will automatically notify Office of Research staff, who will assess whether the activity triggers certain reporting requirements, such as Other Support, Conflict of Interest, etc. Activities that do not involve a foreign engagement will generally not require follow up from the Office of Research. However, our office may request additional information for activities involving an appointment at a foreign institution or conducting research on behalf of a foreign institution.
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Shipments of Biological Materials
The export control office would like to remind all staff and faculty about foreign shipping of biological materials. While most biological research shipments seem innocuous, some biological materials used in basic research may require a license. Please help ensure that all international shipments of research materials are reviewed by the Export Control office.
The University of Indiana recently had 42 violations on shipments of genetically modified fruit flies that were exported without the required export licenses. In the press release linked above Assistant Secretary for Export Enforcement Matthew S. Axelrod stated that, “Researchers should take note: even the smallest items, like a genetically modified fruit fly, can implicate chemical and biological weapons controls…” In this particular case the exports involved fruit flies containing transgenes of a subunit of the ricin toxin. While the transgenes themselves are not considered toxins, an export license is required for shipments to certain destinations.
For additional information there are two different agencies that oversee export controls as it relates to biological research and shipments: the Export Administration Regulations (EAR) governs dual-use items, technologies and software with commercial and military applications and the International Traffic in Arms Regulations (ITAR) oversees materials, technologies and software specially designed for military applications. Failure to comply with regulations when transporting regulated biological materials may result in shipment delays, destruction at the port of entry, refusal of the shipment by carriers, and the individual/institution shipping the items may be subject to fines and/or criminal penalties.
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Revised DOD Instruction (DODI 3216.02) Protection of Human Subjects
On 15 April 2020, the DOD issued an update to DODI 3216.02. Of particular importance that Human Subjects researchers may not be aware of pertains to Section 3.6 which describes, “For DoD-supported research that is exempt or does not involve human subjects, must submit institutional documentation of the determination that the research is either not HSR, exempt HSR, or limited IRB review to the HRPO, to include all protocol documents.”
What this means for researchers who are supported by DOD and may not be conducting human subjects research through traditional means, i.e., interaction or intervention, but are obtaining data or biospecimens about living individuals, for example from a collaborator or a via public repository, you must seek a non-human subjects determination through the Human Subjects Office and submit the determination to your DOD Human Research Protection Officer for review. The form for submitting a request for a non-human subjects research determination can be found on our Forms Page of the Office of Research website. Please note that research which is eligible for an exempt determination continues to be required to be reviewed via ORahs, the online protocol system.
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Cannabis Research Reminder
Cannabis research is any research activity involving the growth, production, procurement, possession, distribution, administering, or use of marijuana. It does not refer to observational research or other research (e.g., policy research) for which a researcher does not grow, produce, procure, possess, distribute, or administer marijuana.
Cannabis is a DEA Schedule I controlled substance. Therefore, despite the state of California's legalization of recreational use of marijuana, any research involving possession, use, distribution or cultivation of marijuana that is conducted in the United States under the auspices of the University of California (regardless of whether or not the research is conducted on a UC campus or UC property) must comply with all applicable federal and state laws and regulations. This means that research involving cannabis (i.e., all parts of the plant Cannabis sativa L.) must be conducted in compliance with U.S. Drug Enforcement Administration regulations and the California Health and Safety Code.
For more information on complying with federal and state laws relating to cannabis research, click here. Prior to proposing or accepting Cannabis research funding, please reach out to Research Integrity (researchintegrity@research.ucsb.edu) for guidance.
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Upcoming Events
Interested in hosting a human subjects webinar for your department, class, or research team? We can present on a variety of topics from recruitment to informed consent. Contact us at hsc@research.ucsb.edu to schedule a webinar today!
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